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AeroLife Ultrasonic Nebulizer Model P2C

by Aerovectrx Corporation

510(k) K053360

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK053360 Date23 Mar 2006ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
CAF
Device Class
Class II
Regulation
21 CFR Part 868.5630
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The AeroLife Ultrasonic Nebulizer Model P2C is a Nebulizer (Direct Patient Interface) designed to convert liquid medication into a fine mist for inhalation therapy. Utilizing ultrasonic technology, it efficiently disperses aerosolized particles, facilitating delivery of respiratory treatments such as bronchodilators, mucolytics, or corticosteroids. This device is classified under product code CAF and is intended for clinical use in administering inhaled medications to patients requiring aerosolized therapy.

The AeroLife Ultrasonic Nebulizer Model P2C is supplied as a reusable medical device and is regulated under FDA 510(k) clearance (K053360), classified as Class II with special controls. It is intended for use in clinical settings, including hospitals and outpatient care, where precise aerosol delivery is required. The device’s design adheres to regulatory standards for direct patient interface devices, ensuring compatibility with standard respiratory therapy protocols. No specific sterility or MRI safety information is provided in the regulatory data.